Hypertension
Conditions
Interventions
Trade Name: Zestril
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Atacand
Pharmaceutical Form: Tablet
Pharmaceut
Sponsors
Uppsala University, Department of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged =40 years and =75 years 2. Previously diagnosed with hypertension with systolic blood pressure between 140 and 159 mm Hg within five years prior to the start of the trial. 3. Pharmacologically untreated or using blood pressure-lowering monotherapy at Visit 1. No blood pressure-lowering medication taken during the placebo run-in period. 4. Office systolic blood pressure between 140 and 179 mm Hg and diastolic blood pressure at or below 109 mm Hg at Visit 2. 5. Patients must give informed consent to participate in the study. 6 Access to a smartphone. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Medical history, clinical signs or laboratory results indicating secondary hypertension. 2. Evidence of serious hematological, respiratory immunological, renal, hepatic, gastrointestinal, endocrinological, metabolic, neurologic, malignant, psychiatric or other diseases as revealed by medical history, physical examination and/or laboratory assessments. 3. Lithium treatment and gout. 4. Previous or present arterial occlusive diseases such as myocardial infarction (MI), stroke or acute arterial insufficiency (unstable angina pectoris or transient ischemic attacks, (TIA)) or heart failure (NYHA class III or IV). 5. Symptomatic hypotension, defined as weakness or syncope upon rising to an erect position associated with a decrease in systolic blood pressure. 6. Patients with diabetes requiring insulin or oral glucose-lowering drugs. 7. Patients with history of serious abnormal drug reaction including angioedema. 8. Patients with any condition associated with poor compliance including alcoholism or drug dependence. 9. Patients who will not comply with the study protocol as judged by the Investigator. 10. Women who are pregnant or lactating or not using appropriate contraception for at least 3 months prior to visit 1. 11. Patient using concomitant medication that can interfere with study medication, and that according to FASS should not be given. 12. Clinical laboratory assessment outside normal range at visit 1 as judged by Investigator. 13. Previous enrolment in present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the potential for precision hypertension care, by investigating if there is a consistent between-person variation in blood pressure response to the common blood pressure-lowering drug classes of a clinically relevant magnitude, given the within-person variation in blood pressure.;Secondary Objective: a) To investigate the between-person variation in side effects of blood pressure-lowering drugs in contrast to the within-person variation in side effects. b) To investigate patient treatment preferences when presented with: i) their individual ratings for each drug class, ii) a combination of their individual ratings and blood pressure effect of each drug class c) To develop a prediction model based on biomarkers and clinical characteristics for patient treatment preferences. d) To develop and evaluate a point-of-care tool using this prediction model, in order to inform treatment decisions in the clinical setting.;Primary end point(s): Between-person variation in blood pressure-lowering effects of blood pressure-lowering drugs, measured as variation in daytime (10-20) ambulatory systolic blood pressure.;Timepoint(s) of evaluation of this end point: Visit 4 of the treatment periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Between-person variation in side effects of blood pressure-lowering drugs. b) The difference in patient treatment preferences between the blood pressure lowering drug classes. c) Overall patient treatment preferences and biomarkers. ;Timepoint(s) of evaluation of this end point: a) Visit 3 of the treatment periods. b) i) At visit 3 of each treatment period ii) After presentation of differences in mean daytime (10:00-20:00) blood pressure and side effects between drug classes. c) Overall patient treatment preferences measured at visit 5 in the last treatment period and biomarkers measured at visit 3 of each treatment period. | — |
Countries
Sweden
Contacts
Public ContactUppsala Clinical Research Center
Uppsala Clinical Research Center
Outcome results
None listed